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Summary of Contents for DeRoyal Prospera PRO Series
- Page 1 USER MANUAL DeRoyal Prospera PRO Series ® ® Negative Pressure Wound Therapy System PRO-II and PRO-III ® ® AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005), CAN/CSA-C22.2 No. 60601-1 SAFETY US-CA E355754 (2008)
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Page 3: Table Of Contents
Connecting the disposable exudate canister of the PRO-II Device ....20 ® 3.1.5 Positioning of the PRO-III ® Device ............20 3.1.6 Connecting the DeRoyal ® disposable exudate canister system of the PRO-III ® Device ....................21 3.1.7 Connecting a wound drainage system ............21 Operation of the PRO-II ®... - Page 4 4.1.4 Disposal of the canister and the suction tube for PRO-III ® Device .....31 Maintenance and Service .................31 Testing the PRO-II or PRO-III Devices ............31 ® ® Function Test ..................32 Troubleshooting ..................32 Error Messages ..................33 Decontamination prior to shipment ............35 Storage ....................35 Disposal ....................35 PRO-II...
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Page 5: Using This Instruction Manual
Include the User Manual when passing the PRO-II or PRO-III ® device onto third • ® parties. For additional copies of the User Manual, contact DeRoyal Customer Service within • the US, please call 1-800-251-9864; internationally please call +1-865-938-7828. Icons 1.2.1 General Symbols Meaning... -
Page 6: Display
Activated automatically during operation and can be canceled by simultaneously pressing the Up and Down buttons. Filter run time elapsed; replacement of the internal filter by an authorized DeRoyal service technician is required. X = Represents Sensitivity of “System closed” alarms Alarm display settings Y = Represents Sensitivity of “Check dressing... -
Page 7: Glossary
Glossary approx. Abbreviation for “approximately” Contamination Contamination means that liquids, exudate, bacteria and/or viruses from the wound or environment have come into contact with the interior of the device. e.g. For example, abbreviation for Latin “exempli gratia” incl. Abbreviation for “inclusive” or “including” IP22 International Protection / Protection Class The Protection Class defines the degree of protection of the device... -
Page 8: Intended Use
Intended Use These negative pressure wound therapy systems are indicated for patients that would benefit from a suction device particularly as the device may promote wound healing by removal of wound exudate, debris, and infectious material or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from the patient's airway or respiratory support system. -
Page 9: Restrictions On Use
Remove the wound dressing if it will interfere with defibrillation. The patient height and weight should be considered before prescribing the DeRoyal • negative pressure wound therapy system. Infants, children, some small adults and elderly patients should be closely monitored for excessive fluid loss and dehydration. - Page 10 Safety defects due to improper accessories and spare parts. The use of accessories, canisters and spare parts other than those recommended by and sold from DeRoyal may compromise the safety and function of the device. Warranty does not cover damage caused by using...
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Page 11: User Requirements
® ® authorized distribution partner of DeRoyal. Product training takes approximately one to two hours and includes an explanation of the design and function of the device, the handling of the device, the alarm system, and the cleaning and disinfection of the device. -
Page 12: Whole View
• • DeRoyal warranty statement optional accessories (depending on the order) • A separate Quick Reference Guide for use of the PRO-II ® device for in-home care is available for download via the internet (www.deroyal.com) under Negative Pressure Wound Therapy. -
Page 13: Pro-Iii ® Device
• • DeRoyal warranty statement optional accessories (depending on the order) • A separate Quick Reference Guide for use of the PRO-III device for in-home care is ® available for download via the internet (www.deroyal.com) under Negative Pressure Wound Therapy. -
Page 14: Product Properties
The PRO-II ® and PRO-III ® devices must only be operated with DeRoyal supplied disposable power supply unit that also is used to recharge the battery. power supply unit that also is used to recharge the battery. exudate canisters. The vacuum is generated by a maintenance-free electric motor driven membrane pump. After The vacuum is generated by a maintenance-free electric motor driven membrane pump. -
Page 15: Information On The Filter System For The Pro-Ii ® Device
(blocked), after the filter service life has expired ( symbol in the display) or during maintenance/repair. The internal filter must be replaced by DeRoyal or an authorized service partner of DeRoyal. 2.2.3 Information on the carbon filter of the PRO-II ®... -
Page 16: Information On The Double Filter System For Pro-Iii ® Device
To ensure consistent performance, the internal filter must be replaced after contact with the exudate (blocked), after the filter service life has expired (8,000 hours) ( symbol in the display) or during maintenance/repair. The internal filter must be replaced by DeRoyal or an authorized service partner of DeRoyal. 2.2.6 Battery The charge level of the battery is shown in the display. -
Page 17: Pressure Settings
DeRoyal at a cost of $75 per hour. A minimum of $75 may be charged and billed appropriately. Any repair charges less than $500.00 will be automatically billed, unless otherwise instructed by customer at time service is requested. - Page 18 ® device is • blocked, the device must be serviced by DeRoyal. or by an authorized service partner of DeRoyal. Hazard of persons due to inadequate monitoring of patient. Adequate monitoring of patients is mandatory in cases of highly exuding wounds, wounds with viscous or strongly deposited exudate and strong bleeding.
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Page 19: Setup And Startup
Setup and Startup 3.1.1 Startup It is important to follow the safety instruction in chapter 1.6 prior to initial startup. Always have one backup disposable exudate canister for the PRO-II ® and one backup disposable canister and tubing for the PRO-III ®... -
Page 20: Positioning Of The Pro-Ii ® Devices
Device The PRO-III ® device can be placed next to the patient bed or attached via the DeRoyal PRO- ® device bed holder (NP-140). An optional carrying bag (NP-3001) is available for portable use, as well as IV Pole holder. Note: The PRO-III carrying bag is single patient use. -
Page 21: Connecting The Deroyal ® Disposable Exudate Canister System Of The Pro-Iii ® Device
3.1.7 Connecting a wound drainage system TopDraw Connect the suction tube to the wound drainage system, such as the DeRoyal ® ® Medium Black foam Kit with Triple Release Transeal ®... -
Page 22: Operation Of The Pro-Ii ® And Pro-Iii ® Devices
PRO-III ® device. The following start screen is displayed for 5 seconds: DeRoyal 2. At initial startup the unit will open with Continuous Mode set to -80mmHg: 3. Use the arrow buttons to select the Language menu. 4. Use the button to confirm your choice. -
Page 23: Continuous Operation
® or PRO-III ® . The following start screen is displayed for 5 seconds: DeRoyal 2. While the start screen is displayed, simultaneously press the arrow buttons. The menu Setup is displayed. 3. Use the arrow buttons to select the Continuous menu. -
Page 24: Intermittent Operation
1-2 seconds to switch on the PRO-II ® or PRO-III ® . The following start screen is displayed for 5 seconds: DeRoyal 2. While the start screen is displayed, simultaneously press the arrow buttons. The menu Setup is displayed. - Page 25 3. Use the arrow buttons to select the Intermittent menu. 4. Use the button to confirm your choice. 5. Use the arrow buttons to set the prescribed high vacuum value. 6. Confirm the setting by pressing the button. 7. Use the arrow buttons to set the prescribed low vacuum value.
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Page 26: Language Selection
PRO-III devices. The ® ® following start screen is displayed for 5 seconds: DeRoyal 2. While the start screen is displayed, simultaneously press the arrow buttons. The menu Setup is displayed. 3. Use the arrow buttons to select the Language menu. -
Page 27: Patient Mode
The authorization code may only be passed to specially trained personnel. You will get the training and the authorization code by DeRoyal or an authorized distribution partner of DeRoyal. Passwords must be treated as confidential information to prevent misuse. - Page 28 6. The sensitivity setting of the alarm “Check dressing seal” is now displayed. The sensitivity can be adjusted with the arrow buttons. “L” high sensitivity low sensitivity default See Below Displays as: (rapid triggering of (delayed triggering Leakage the alarm) of the alarm) System When the sensitivity is set to Leakage System or “0,”...
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Page 29: Canister Exchange
Canister Exchange 3.4.1 Replacement of the disposable canister of the PRO-II Device ® 1. Close the tubing clamp at the wound drainage system (fig.3) to maintain the vacuum in the PRO-II ® device. 2. Switch off the PRO-II ® device. 3. -
Page 30: Cleaning And Care
ATTENTION! surface compatibility as well as the concentration information. DeRoyal recommends Incidin LIQUID for wipe and spray • disinfection of the device. Disinfection is not mandatory if the device is used for one patient only (in in-home care). -
Page 31: Device
DeRoyal in compliance with the service documentation specified by the manufacturer as well as with technical and hygienic precautionary measures. The device may be sent back for repair to DeRoyal directly or via the specialty dealer from which the device was purchased. -
Page 32: Function Test
Internal filter is blocked. • Finalize the selection (please • Device is still in the refer to 3.2) and start the • Setup mode. device. Contact DeRoyal or your service partner if the malfunction cannot be corrected by the described measures. -
Page 33: Error Messages
Error Messages • The alarms are solely system-triggered alarms since these are identified by the monitoring of device-specific variables. All alarm messages (except “Internal error”) must be confirmed by • pressing the OK button. Alarm messages of high priority are shown in the display with a red •... - Page 34 The therapy was not Start therapy. minutes). initiated. Current operating The device was not Switch off the device. mode continues to switched off. run in the background. Contact DeRoyal or your service partner if the malfunction cannot be corrected by the described measures.
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Page 35: Decontamination Prior To Shipment
® ® properly cleaned and disinfected. DeRoyal offers its partners and customers fast and proper instructions as well as required testing services. (Please refer to chapter 4). The PRO-II and PRO-III devices must be cleaned and disinfected prior to shipment to ®... -
Page 36: Pro-Ii ® Device
Disposable exudate canister (250 ml or 450 ml) Suction tube with silicone tubing connector ~ length Suction tube 150 cm FRIWO FW 7555M/12 or DeRoyal supplied power Power supply unit adapter In: AC 100 – 240 V~ / 50-60 Hz / 350 – 150 mA Nominal voltage of the power In (UL only): 120 Vac / max. -
Page 37: Pro-Iii ® Device
Pressure Conversion factor: 1 kPa ~ 7.5 mmHg Canister Disposable exudate canister system (800 cc) FRIWO FW 7555M/12 or DeRoyal supplied power Power supply unit adapter In: AC 100 – 240 V~ / 50-60 Hz / 350 – 150 mA Nominal voltage of the power In (UL only): 120 Vac / max. -
Page 38: Emc Information
Portable and mobile RF communication equipment may affect medical electrical equipment! Do not apply any 3 party device to unit without ATTENTION! proper testing performed by DeRoyal or by authorized professionals of DeRoyal. The use of any accessories and/or spare parts (incl. transformers and cables, non-permanent 3 party devices, etc.) not recommended by... - Page 39 Table 1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The PRO-II and PRO-III devices are intended for operation in the electromagnetic ® ® environment specified below. The customer or the user of the PRO-II ® or PRO-III ® device must ensure that it is operated in such an environment. Electromagnetic Environment Emissions measurement Compliance...
- Page 40 Electromagnetic Immunity test IEC 60601 test level Compliance level Environment – Guidance ±1kV voltage ±1kV voltage Main supply voltage Interference differential mode differential mode should be of the same voltages / Surges quality as in a typical pursuant to ±2kV common ±2kV common commercial, living or IEC 61000-4-5...
- Page 41 Table 3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The PRO-II ® and PRO-III ® devices are intended for operation in the electromagnetic environment specified below. The customer or user of the PRO-II ® or PRO-III ® device must ensure that it is used in such an environment.
- Page 42 NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
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Page 43: Pro-Ii ® Device
Description Item number new Pro-2 NP-2000 PRO-II ® Portable Negative Pressure Device Power supply unit FRIWO FW 7555M/12 or DeRoyal NP-2002 supplied power supply Disposable exudate canister (250 ml) with solidifier NP-0250 yes (2) and integrated tubing Disposable exudate canister (400 ml) with solidifier... - Page 44 DeRoyal, the DeRoyal logo, and Improving Care. Improving Business, Prospera, Prospera Negative Pressure Wound Therapy, PRO-II, and PRO-III, Transeal, and TopDraw are trademarks or registered trademarks of DeRoyal Industries, Inc. (“DeRoyal”). UL and the UL logo are registered trademarks of UL LLC.
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